Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)

What this Trial Is About

Researchers are evaluating the safety and feasibility of using a balanced 1:1 ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD) cannabis oil as an additional therapy to methadone-based opioid agonist therapy (OAT) for individuals with opioid use disorder (OUD). This pilot study is conducted in a community setting and involves adults diagnosed with OUD who have recently started or restarted methadone treatment. The trial is designed as a Phase II, placebo-controlled, double-blind study to assess these treatments over a 12-week period. The study has two phases. In Phase 1, 24 participants are randomly assigned to receive either the THC:CBD cannabis oil or a placebo oil alongside their methadone therapy. The cannabis oil or placebo is self-administered sublingually with an initial dose of 5 mg per day, which can be adjusted with medical guidance up to a maximum of 40 mg per day. After completing Phase 1, eligible participants may join Phase 2, a 12-week open-label extension where all receive the THC:CBD cannabis oil. Research visits occur every two weeks during this extension. Participants will be involved in regular assessments including safety monitoring, adherence to treatment, and acceptability of the cannabis oil. Researchers will track treatment-emergent adverse events, the risk of treatment contamination, dose adequacy, and blinding effectiveness over 24 to 28 weeks. Other measures include enrollment rates, screening failure rates, and visit completion. The full study duration covers screening, two treatment phases, and follow-up visits to ensure thorough evaluation of the therapy combination.

Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy